Lower back pain from a herniated disc? Vancouver General Hospital trial seeks volunteers for ozone treatment

May 24/2013 note to readers: Since the publication of my story below, the hospital has been swamped with callers. Many who want to join the study are frustrated by the inadequate voicemail system and have called me to complain. So the trial sponsor is providing additional contact information: Tami Forsgren, email is tamif.activeo@gmail.com and phone number is 801-928-1701.

“There was a strong suggestion that patients got better more rapidly with the treatment. What we’re hoping to see here is that through the ozone process, healing will occur rapidly and patients won’t need other interventions like repeated steroid (cortisone) injections and surgery.”

This is the analogy he used to describe the problem of herniated discs:

“The disc is like a fibrous doughnut and you get a herniation when an inner part of the disc bulges out through a weakened area.”

Munk said the vast majority (95 per cent) of herniations occur in the lower back (lumbar) area, where they cause pain in the back and legs by pinching on spinal nerves.

The main objective of the clinical trial, now recruiting 25 participants, is to assess the safety of a new Canadian-engineered injection delivery system for the ozone-oxygen therapy. But effectiveness will also be monitored and patients will be followed at regular intervals.

Discs are like the shock absorbers between the vertebrae. The experimental treatment requires radiologists to use CT imaging so they can guide the needle precisely into the centre of the herniated disc.

The procedure takes 20 minutes and, as an outpatient service, should cost the health care system far less than surgery, according to ActiveO, Inc., the Nevada/Utah company sponsoring the trial since it owns the rights to the AO-1000 treatment. It was developed by Toronto radiologist, Dr. Kieran Murphy, of the University Health Network.

The injectable gas treatment is widely used in Asia and Europe but Murphy’s invention is a new hand-held device which utilizes a special syringe to deliver the treatment. The conventional system is more cumbersome as it uses ozone from massive machines that can only be located in certain hospital settings.

The new system involves an oxygen supply from a small canister. Oxygen is drawn into the syringe and with the flick of a button on the hand-held device, an electrical charge generates ozone that is then injected into the lower back area.

Stages of Spinal Disc Herniation (Photo credit: Wikipedia)

Surgery is usually reserved for the worst cases, and involves removal of a portion of the diseased disc and fusion of the vertebrae.

Munk said the ozone-oxygen treatment is not meant for the worst cases. It’s intended for the most common types — bulging (contained) herniated discs.

Although infection, bleeding and embolisms are worst-case complications of the ozone treatment, previous studies have shown such risks are less than one per cent or one in 1,500 patients.

Even though the new device is being used on humans for the first time (it was previously tested in animals) ActiveO says the design of the device and the use of imaging guidance should all but eliminate risks.

According to the meta-analysis of ozone treatments for herniated lumbar discs, published in the Journal of Interventional Radiology, Italians were the first to inject one to three ml of ozone/oxygen into herniated discs in the 1990s. The study was partly funded by ActiveO, and authors, including Murphy, declared direct or indirect financial relationships with the company.

While ozone therapy has been used extensively in other parts of the world for disc herniation treatment, it is still considered a toxic gas when inhaled and it is controversial as an alternative treatment for other diseases.

Alternative health practitioners have touted it as a remedy because it has been shown to deactivate disease particles in laboratory situations. But there’s a paucity of evidence to support the theory that ozone increases oxygen in the body and that cancer or other diseases won’t thrive in a high oxygen environment.

Today’s Vancouver Sun – printed version, with my story on front page.

For more information on enrolment in the VGH disc herniation trial, call 604-875-4612. Because of my story, apparently, the phone lines have been jammed by callers interested in joining the study. Please be patient and just keep trying.

For those living outside of BC, Munk said hospitals in Alberta (Edmonton) and Ontario (London and Toronto) are also expected to participate in the trial.